Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Staff Engineer, Device Development in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Staff Engineer working on the Device Development team, you will be empowered to build relationships with internal and external stakeholders and influence multiple areas of the device development process.
- Manage the design and development of medical devices and combination products for Takeda pipeline.
- Work with cross functional stakeholders to determine device requirements and oversee design, testing, and manufacturing of devices and combination products at external partners.
- Lead teams to evaluate and select appropriate device technologies for Takeda s pipeline assets
- Build and maintain relationships with key vendors and assists with technical aspects of vendor negotiations
- Represent device development function at CMC and other cross functional teams and plans resources to execute specific project tasks.
- Plans and implements resolutions to technical problems/issues
- Monitor device competitive landscape and update development plans accordingly
- Provide input on device packaging, labeling, and instructions for use
- Manage preparation of device for human factors and market research studies
- Oversee the GMP production of clinical devices at external partners
EDUCATION, EXPERIENCE AND SKILLS:
- Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related fields:
- BS/BA Degree with 8+ years relevant industry experience
- MS/MA Degree with 6+ years relevant industry experience
- PhD with 1+ relevant industry experience
- Experience in developing combination drug delivery devices under Design Control (21CFR820) and ISO 14791 requirements
- Experience with human factor studies
- Experience managing external design, development and cGMP manufacturing partners
- Strong technical leadership and communications skills
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.